MAGLUMI Rubella IgG (CLIA)

130212003M INTENDED USE

100 The kit has been designed for the qualitative determination of
Rubella IgG in human serum
The test has to be performed on the Fully-auto
chemiluminescence immunoassay (CLIA) analyzer MAGLUMI
(Including Maglumi 600,Maglumi 1000,Maglumi 1000 Plus,
Shenzhen New Industries Lotus Global Co., Ltd Maglumi 2000,Maglumi 2000 Plus,Maglumi 3000 and Maglumi
Biomedical Engineering Co., Ltd 15 Alexandra Road 4000).
4/F,Wearnes Tech Bldg, London
Science & Industry Park, UK SUMMARY AND EXPLANATION OF THE TEST
Nanshan,Shenzhen,518057CHINA NW8 0DP Rubella is a viral exanthematous infectious disease caused by
Tel. + 86-755-86028224 Tel. + 44-20-75868010 rubella virus, a single-stranded RNA virus belonging to the
Fax.+ 86-755-26654850 Fax.+ 44-20-79006187 Togavirus group. The illness follows a typically benign clinical
course with rare complications and is subclinical in a large
proportion of cases. Symptomatology is generally mild,

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characterized by fever, malaise, a maculopapular rash of three to
FOR PROFESSIONAL USE ONLY five days' duration and, possibly, coryza and conjunctivitis. The
Store at 2-8 °C disease is usually accompanied by lymphadenopathy. Infection
confers lifelong immunity.

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Infection from rubella virus is particularly disastrous if contracted
COMPLETELY READ THE INSTRUCTIONS BEFORE
during the first four months of gestation. If not immunologically
PROCEEDING
protected, women infected during pregnancy run a high risk of
embryo foetal damage. Congenital rubella causes a wide range of
severe defects, many of which are permanent and adversely affect
later development (cataract, deafness, hepatosplenomegaly,
SYMBOLS EXPLANATIONS psychomotor retardation, bone alterations, cardiopathies, and
Authorized Representative in the neuropathies). Pathological consequences on the foetus or
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European community
newborn depend on teratogenicity of the virus and on the time of
pregnancy when the infection has been contracted. Gestational
Manufacturer age at the time of maternal infection is considered the most
important determinant of intrauterine transmission and foetal
damage. It is generally accepted that the risk decreases with
Consult instructions for use
increasing gestational age: it is highest in case of infection during
the first two months of pregnancy (40-60%) and progressively
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Contents of kit decreases during the fourth and fifth months (10-20%). Clinical
findings in newborns and virus isolation studies have
demonstrated that foetal infection is rare beyond the second
In vitro diagnostic medical device trimester of gestation.
Rubella virus is transmitted in utero during the course of primary
maternal infection, whether apparent or inapparent, when the virus
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Batch code
in the bloodstream infects the placenta and, subsequently, the
foetus. Intrauterine transmission of virus associated with maternal
Catalogue number re-infection is extremely rare, indicating that maternal immunity
(whether naturally derived or vaccine-induced) protects against
intrauterine infection. Maternal infection may result in (a) no
Use by infection of the embryo; (b) resorption of the embryo (seen only
with infections occurring in the earliest stages of gestation); (c)
miscarriage; (d) stillbirth; (e) infection of placenta without foetal
Temperature limitation involvement or (f) infection of both the placenta and foetus.
( store at 2-8 °C) Infected infants may present obvious multiple organ involvement
or, as is frequently observed, no immediately evident disease.
However, after long-term follow-up, many of these seemingly
Sufficient for
unaffected infants have evidence of hearing loss, or central
nervous system lesions, or other defects.
The first humoral immune response to infection is the synthesis of
Keep away from sunlight
specific anti-rubella virus IgM antibody which reaches high serum
levels two weeks after the rash and lasts in the circulation for one
to two month(s). Specific IgG antibody generally appears a few
Keep upright for storage days after the onset of rash, about one week after IgM develops. It
rapidly increases to reach a plateau six to ten weeks after the
onset of symptoms and then progressively decreases to a level
(15-200 IU/ml) lasting for the whole life. Reinfection, completely
asymptomatic, is accompanied by moderately increased levels of
076130806-V2.5-EN 1/4
specific IgG. reagents or lots!
Correct detection of IgM and IgG antibodies to rubella virus
provides an essential tool for diagnosing and following up acute Storage and Stability
infection, for assessment of immune status in fertile women,  Sealed: Stored at 2-8℃ until the expiry date.
and therefore for adopting suitable prophylaxis in susceptible  Opened: Stable for 4 weeks. To ensure the best kit performance,
women of child-bearing age. Since when a vaccine was made it is recommended to place opened kits in the refrigerator if it’s not
available, the assay of IgG to rubella virus has been widely used to going to be used on board during the next 12 hours.
determine seroconversion of the recipient after vaccination.

PRINCIPLE OF THE TEST  Keep upright for storage.

Indirect immunoluminometric assay;
Mouse anti-human IgG is used to label ABEI, and use purified
Rubella antigen to coat nano magnetic microbeads. Sample,  Keep away from sunlight.
Calibrator or Control with Buffer （goat Anti-human IgM, goat
Anti-human IgA） and nano magnetic microbeads coated with CALIBRATION AND TRACEABILITY
Rubella antigen are mixed thoroughly and incubated at 37℃ and 1) Traceability
cycle washing for 1 time. Then add ABEI Label, incubation and To perform an accurate calibration, we have provided the test
form a sandwich, then washing for the 2nd time. Subsequently, the calibrators standardized against the SNIBE internal reference
starter reagents are added and a flash chemiluminescent reaction substance.
is initiated. The light signal is measured by a photomultiplier as Calibrators in the Reagent Kit are from Fitzgerald.
2) 2-Point Recalibration

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RLU within 3 seconds and is proportional to the concentration of
Rubella IgG present in samples. Via the measurement of calibrators, the predefined master curve is
adjusted (recalibrated) to a new, instrument-specific measurement
level with each calibration.

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KIT COMPONENTS 3) Frequency of Recalibration
Material Supplies  After each exchange of lots (Reagent Integral or Starter

Reagents).
Reagent Integral for 100 determinations
 Every 4 weeks and/or each time a new Integral is used
Nano magnetic microbeads: TRIS buffer,
(recommendation).
1.2% (W/V), 0.2%NaN3, coated with Rubella 2.5ml
 After each servicing of the Fully-auto chemiluminescence
antigen.
Calibrator Low: bovine serum, 0.2%NaN3. immunoassay (CLIA) analyzer MAGLUMI.
2.5ml
 If controls are beyond the expected range.
Calibrator High: vine serum, 0.2%NaN3.
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2.5ml
Buffer: sheep anti-human IgA, sheep  The room temperature has changed more than 5 ℃
22.5ml (recommendation)
anti-human IgM containing BSA, 0.2%NaN3.
ABEI Label: Mouse anti-human IgG
monoclonal antibody labeled ABEI, contains 22.5ml SPECIMEN COLLECTION AND PREPARATION
BSA, 0.2%NaN3 Sample material: serum
All reagents are provided ready-to-use. Collect 5.0ml venous blood into Blood Collection Tube (Tube
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without anticoagulant or coagulant, Anticoagulation tube with

Reagent Vials in kit box EDTA-K2 or EDTA-Na4 can be used. Anticoagulation tube with
Internal Quality Control: containing BSA, heparin sodium is not recommended).
0.2%NaN3. (target value refer to Quality 2.0ml Standing at room temperature，centrifuging, separating serum part.
Control Information date sheet). The serum sample is stable for up to 12 hours at 2-8 ℃. If
Internal quality control is only applicable with MAGLUMI system. preserved for more than 12 hours, please packed, -20 ℃ can be
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Instructions for use and target value refer to Quality Control stored for 30 days.
Information date sheet. User needs to judge results with their own Avoid repeated freezing and thawing, the serum sample can be
standards and knowledge. only frozen and thawed two times. Stored samples should be
thoroughly mixed prior to use (Vortex mixer).
Accessories Required But Not Provided Please ask local representative of SNIBE for more details if you
MAGLUMI Reaction Module REF: 630003 have any doubt.
MAGLUMI Starter 1+2 REF: 130299004M
MAGLUMI Wash Concentrate REF: 130299005M Vacuum Tubes
MAGLUMI Light Check REF: 130299006M (a) Blank tubes are recommended type for collecting samples.
Please order accessories from SNIBE or our representative. (b) Please ask SNIBE for advice if special additive must be used in
sample collecting.

Specimen Conditions
• Do not use specimens with the following conditions:
Preparation of the Reagent Integral
(a) heat-inactivated specimens;
Before the sealing is removed, gentle and careful horizontal
(b) Cadaver specimens or body fluids other than human serum;
shaking of the Reagent Integral is essential (avoid foam formation!)
(c) Obvious microbial contamination.
Remove the sealing and turn the small wheel of the magnetic
• Use caution when handling patient specimens to prevent cross
microbeads compartment to and fro, until the colour of the
contamination. Use of disposable pipettes or pipette tips is
suspension has changed into brown. Place the Integral into the
recommended.
reagent area and let it stand there for 30 min. During this time, the
• Inspect all samples for bubbles. Remove bubbles with an
magnetic microbeads are automatically agitated and completely
applicator stick prior to analysis. Use a new applicator stick for
resuspended.
each sample to prevent cross contamination.
Do not interchange integral component from different
076130806-V2.5-EN 2/4
 • Serum specimens should be free of fibrin, red blood cells or hour at 121℃ is usually considered adequate, though the
other particulate matter. users must check the effectiveness of their decontamination
• Ensure that complete clot formation in serum specimens has cycle by initially validating it and routinely using biological
taken place prior to centrifugation. Some specimens, indicators.
especially those from patients receiving anticoagulant or  It is recommended that all human sourced materials be
thrombolytic therapy, may exhibit increased clotting time. If the considered potentially infectious and handled in accordance
specimen is centrifuged before a complete clot forms, the with the OSHA Standard on Bloodborne Pathogens13.
presence of fibrin may cause erroneous results. Biosafety Level 214 or other appropriate biosafety practices
should be used for materials that contain or are suspected
Preparation for Analysis of containing infectious agents.
• Patient specimens with a cloudy or turbid appearance must be  This product contains Sodium Azide; this material and its
centrifuged prior to testing. Following centrifugation, avoid the container must be disposed of in a safe way.
lipid layer (if present) when pipetting the specimen into a  Safety data sheets are available on request.
sample cup or secondary tube. Handling Precautions
• Specimens must be mixed thoroughly after thawing by low • Do not use reagent kits beyond the expiration date.
speed vortexing or by gently inverting, and centrifuged prior to • Do not mix reagents from different reagent kits.
use to remove red blood cells or particulate matter to ensure • Prior to loading the Reagent Kit on the system for the first time,
consistency in the results. Multiple freeze-thaw cycles of the microbeads requires mixing to re-suspend microbeads
specimens should be avoided. that have settled during shipment.
• All samples (patient specimens or controls) should be tested • For microbeads mixing instructions, refer to the KIT
within 3 hours of being placed on board the MAGLUMI COMPONENTS, Preparation of the Reagent Integral section

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System. Refer to the SNIBE service for a more detailed of this package insert.
discussion of onboard sample storage constraints. • To avoid contamination, wear clean gloves when operating
with a reagent kit and sample.
Storage • Over time, residual liquids may dry on the kit surface, please

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• If testing will be delayed for more than 8 hours, remove serum pay attention the silicon film still exists on the surface of the kit.
from the serum separator, red blood cells or clot. Specimens • For a detailed discussion of handling precautions during
removed from the separator gel, cells or clot may be stored up system operation, refer to the SNIBE service information.
to 12 hours at 2-8°C.
• Specimens can be stored up to 30 days frozen at -20°C or TEST PROCEDURE
colder. To ensure proper test performance, strictly adhere to the operating
instructions of the Fully-auto chemiluminescence immunoassay
Shipping (CLIA) analyzer MAGLUMI. Each test parameter is identified via a
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• Before shipping specimens, it is recommended that specimens RFID tag on the Reagent Integral. For further information please
be removed from the serum separator, red blood cells or clot. refer to the Fully-auto chemiluminescence immunoassay (CLIA)
When shipped, specimens must be packaged and labeled in analyzer MAGLUMI Operating Instructions.
compliance with applicable state, federal and international
10μl Sample, calibrator
regulations covering the transport of clinical specimens and
+200μl Buffer
infectious substances. Specimens must be shipped frozen
+20μl Nano magnetic microbeads
(dry ice). Do not exceed the storage time limitations identified
10 min Incubation
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in this section of the package insert.

400μl Cycle washing
+200μl ABEI Label
WARNING AND PRECAUTIONS FOR USERS
10 min Incubation
400μl Cycle washing
3s Measurement
 For use in IN-VITRO diagnostic procedures only. * Do not interchange magnetic microbeads from different lots.
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 Package insert instructions must be carefully followed.

Reliability of assay results cannot be guaranteed if there are
QUALITY CONTROL
any deviations from the instructions in this package insert.
 Observe quality control guidelines for medical laboratories
 Use suitable controls for in-house quality control. Controls
Safety Precautions
should be run at least once every 24 hours when the test is in
CAUTION: This product requires the handling of human
use, once per reagent kit and after every calibration. The
specimens.
control intervals should be adapted to each laboratory’s
 The calibrators in this kit are prepared from bovine serum
individual requirements. Values obtained should fall within the
products. However, because no test method can offer
defined ranges. Each laboratory should establish guidelines
complete assurance that HIV, Hepatitis B Virus or other
for corrective measures to be taken if values fall outside the
infectious agents are absent; these reagents should be
range.
considered a potential biohazard and handled with the same
precautions as applied to any serum or plasma specimen.
 All samples, biological reagents and materials used in the LIMITATIONS OF THE PROCEDURE
assay must be considered potentially able to transmit 1) Limitations
infectious agents. They should therefore be disposed of in Use Rubella IgG value as a kind of auxiliary material for other
accordance with the prevailing regulations and guidelines of testing data when in diagnosis. Assay results should be utilized in
the agencies holding jurisdiction over the laboratory, and the conjunction with other clinical and laboratory data to assist the
regulations of each country. Disposable materials must be clinician in making individual patient management decisions
incinerated; liquid waste must be decontaminated with A skillful technique and strict adherence to the instructions are
sodium hypochlorite at a final concentration of 5% for at necessary to obtain reliable results. Bacterial contamination of
least half an hour. Any materials to be reused must be samples or repeated freeze-thaw cycles may affect the test results.
autoclaved using an overkill approach. A minimum of one Assay results should be utilized in conjunction with other clinical
076130806-V2.5-EN 3/4
and laboratory data to assist the clinician in making individual negative.
patient management decisions.
4) Recovery
2) Interfering Substances Consider calibrator high of known concentration as a sample,
No interference with test results is seen by concentrations of dilute it by 1:2 ratio with diluents, and measure its diluted
bilirubin ≤ 0.4mg/ml, haemoglobin ≤ 10mg/ml ， Triglycerides ≤ concentration for 10 times. Then calculate the recovery of
20mg/ml. measured concentration and expected concentration. The
recovery should be within 90% -110%.
3) HAMA Expected Mean Measuring Recovery
Patient samples containing human anti-mouse antibodies (HAMA) 9.8 AU/ml 9.9 AU/ml 101%
may give falsely elevated or decreased values. Although
HAMA-neutralizing agents are added, extremely high HAMA
serum concentrations may occasionally influence results. REFERENCES
1. Lisa Byrne, Lisa Brant, Claire Reynolds, Mary Ramsay,
RESULTS Vaccine, Volume 30, Issue 2, 5 January 2012, Pages 161-167.
1) Calculation of Results 2. Blenda Böttiger, Inge Panum Jensen, Clinical and Diagnostic
 The analyzer automatically calculates the Rubella IgG Virology, Volume 8, Issue 2, August 1997, Pages 105-111.
concentration in each sample by means of a calibration curve 3. Mohammed-Durosinlorun Amina, Shittu Oladapo, Sadauki
which is generated by a 2-point calibration master curve Habib, Olayinka Adebola, Kolawole Bimbo, Adejo Daniel,
procedure. The results are expressed in AU/ml. For further International Health, Volume 2, Issue 2, June 2010, Pages
information please refer to the Fully-auto chemiluminescence 156-159.

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immunoassay (CLIA) analyzer MAGLUMI Operating 4. H.I.J. Thomas, P. Morgan-Capner, Journal of Virological
Instructions. Methods, Volume 31, Issues 2–3, February–March
1991, Pages 219-228.
2) Interpretation of Results

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5. Klaus-Peter Wandinger, Sandra Saschenbrecker, Katja
Results obtained with the MAGLUMI Rubella IgG assay can be Steinhagen, Thomas Scheper, Wolfgang Meyer, Uwe Bartelt,
interpreted as follows: Gisela Enders, Journal of Virological Methods, Volume 174,
 Non-reactive: A result less than 2 AU/ml ( < 2 AU/ml ) is
Issues 1–2, June 2011, Pages 85-93.
considered to be negative.
6. Giuseppe Portella, Claudio Galli, for the MIGHT (Multicenter
 Reactive: A result greater than or equal to 2 AU/ml is ( ≥ 2
Italian Group for Hospital ToRCH evaluation), Journal of Clinical
AU/ml ) considered to be positive.
Virology, Volume 49, Issue 2, October 2010, Pages 105-110.
Results from assays of other manufacturers cannot be used
7. A. Paris-Hamelin, S. Fustec-Ibarboure, Journal of Virological
interchangeably.
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Methods, Volume 10, Issue 4, April 1985, Pages 355-361
8. Best, J. M., S. O'Shea, G. Tipples, N. Davies, S. M. Al Khusaiby,
PERFORMANCE CHARACTERISTICS
A. Krause, L. M. Hesketh, L. Jin, and G. Enders. 2002.
1) Precision
Interpretation of rubella serology in pregnancy—pitfalls and
Intra-assay coefficient of variation was evaluated on 3 different
problems. BMJ 325:147-148.
levels of control serum repeatedly measured 20 times in the same
9. Dwyer, D. E., P. W. Robertson, and P. R. Fields. 2001.
run, calculating the coefficient of variation.
Broadsheet: clinical and laboratory features of rubella.
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Intra-assay precision
Pathology 33:322-328.
Control Mean(AU/ml) SD(AU/ml) CV%
Level 1 1.61 0.09 5.86 10. Field, P. R., V. Sintchenko, and G. L. Gilbert. 1998.
Level 2 8.15 0.48 5.89 Confirmation of rubella infection: review of 10 years’ experience
Level 3 19.55 1.10 5.65 at ICPMR. Inoculum 7:1-3.
Inter-assay coefficient of variation was evaluated on three batches
11. Francis, B. H., A. K. Thomas, and C. A. McCarty. 2003. The
of kits. Repeatedly measured 3 different levels of control serum 21
impact of rubella immunization on the serological status of
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times, calculating the coefficient of variation.

women of childbearing age: a retrospective longitudinal study in
Inter-assay precision Melbourne, Australia. Am. J. Public Health 93:1274-1276
Control Mean(AU/ml) SD(AU/ml) CV%
Level 1 1.57 0.14 8.85 12. Gutiérrez, A., M. J. Rodríguez, F. De Ory, G. Piédrola, and M.
Level 2 8.24 0.70 8.55 C. Maroto. 1999. Reliability of low-avidity IgG and of IgA in the
Level 3 19.24 1.59 8.26 diagnosis of primary infection by rubella virus with an adaptation
of a commercial test. J. Clin. Lab. Anal. 13:1-4.
2) Analytical Sensitivity
The sensitivity is defined as the concentration of Rubella IgG
equivalent to the mean RLU of 20 replicates of the zero standard
plus two standard deviations corresponding to the concentration
from the standard curve. The sensitivity is typically less than 0.25
AU/ml.

3) Specificity
The specificity of the Rubella IgG assay system was assessed by
measuring the apparent response of the assay to various
potentially cross reactive analytes:
When CMV IgG, CMV IgM, Rubella IgM, Toxo IgG, Toxo IgM,
HSV-1/2IgG, HSV-1/2IgM separately reach a concentration of
30AU/ml, measured Rubella IgG is negative. No cross reaction
with the IgG or IgM antibody of HAV, HBV, HCV, HIV, syphilis,
EBV. The ELISA diagnosed RF or ANA positive, which is non
Rubella infected sample, this reagent’s determination results show
076130806-V2.5-EN 4/4